Investigation of Novel Procedure for Methacholine Challenge Testing

Volumetric Versus Standard Two Minute Tidal Breathing Methodology for Methacholine Challenge Testing

The study will compare a novel volumetric method (performed with the Aerogen Solo vibrating mesh nebulizer) with the standard two-minute tidal breathing protocol (performed with the Wright jet nebulizer) for methacholine challenge testing. The results will then give an indication as to whether the novel technique accurately assesses a given dose of methacholine with the new Aerogen Solo device. In addition, the reproducibility of test results with each method will be examined. Altogether, the findings from this investigation may provide means for better standardization of current testing guidelines.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: Aerogen Solo Nebulizer; Device: Wright Nebulizer

Detailed Description

Fifteen asthmatics will be recruited and tested at the University of Saskatchewan for this randomized, two-way crossover study. Two testing methodologies will be performed, the volumetric method with the Aerogen Solo nebulizer and the two-minute tidal breathing method with the Wright nebulizer.

Participants will undergo four methacholine challenges plus a screening methacholine challenge. However, screening is omitted with participants who have completed a methacholine challenge in the last six months. Of the four study challenges, two will utilize the Wright nebulizer with the two-minute tidal breathing method outlined in the 1999 American Thoracic Society Guidelines for Methacholine Challenge Testing. The remaining two challenges will utilize the Aerogen Solo nebulizer with the volumetric method. The timing of the spirometric manoeuvers and the duration of each inhalation cycle will be consistent with both testing methods. Each challenge will be stopped when the participant's forced expiratory volume in 1 second (FEV1) drops by at least 20%. This allows determination of aPC20 (provocative concentration of methacholine causing a 20% fall in FEV1), which will be converted to aPD20 (provocative dose). A minimum 24-hour washout period between challenges will be used.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Asthma Research Lab - University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women aged 18 or older
• Stable asthma
• Baseline methacholine PC20 less than or equal to 16mg/mL
• Baseline lung function equal or greater than 65% of predicted FEV1

Exclusion Criteria:

• Use of long-acting bronchodilators within 7 days of visit 1
• Pregnant or nursing women
• Cardiovascular problems
• Upper respiratory tract infection within 4 weeks of visit 1
• Allergy-induced asthma exacerbation within 4 weeks of visit 1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aerogen Solo; Volumetric method of methacholine challenge testing performed using the Aerogen Solo nebulizer	Device: Aerogen Solo Nebulizer; Aerogen Ltd., Galway, Ireland
Active Comparator: Wright; Two-minute tidal breathing method of methacholine challenge testing performed using the Wright nebulizer	Device: Wright Nebulizer; Roxon Medi-Tech, Montreal, QC, Canada

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Methacholine PD20 values of two nebulizers, each with a different testing protocol	Do the nebulizers produce similar responses at the same dose	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparability of PD20 values with a single nebulizer over two methacholine challenges	Does a nebulizer produce similar PD20 results with repeat testing	2 weeks

Collaborators and Investigators

• Sponsor: University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 14, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: methacholine, airway hyperresponsiveness
• Other Study ID Numbers: MCT-SOLOWRIGHT-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No